Identity
- Trade Name
- Rampart One Lumbar Interbody Fusion System FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Device Name
- Rampart One Guide, 10.5mm FDA UDI
- Model / Reference
- 49-12-10 FDA UDI
- Description
- Rampart One Guide, 10.5mm FDA UDI
Identifiers
- Catalog Number
- 490-0001 FDA UDI
- Primary DI / UDI-DI
- M7404900001 FDA UDI
- 510(k) Number
- K191091 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Polymeric spinal fusion cage, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Height — 10.5 Millimeter FDA UDI
Category: Polymeric spinal fusion cage, sterile
Rampart One Lumbar Interbody Fusion System by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric spinal fusion cage, sterile.
- TALOS® IBF — MEDITECH SPINE, LLC · Class II
- ROCCIA — Silony Medical GmbH · Class II
- TiNano — AURORA SPINE, INC. · Class II
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
- Aurora Spine — AURORA SPINE, INC. · Class II
- TALOS®-C — MEDITECH SPINE, LLC · Class II
- Avenue T — Ldr Spine USA · Class II
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
Cleared under the same submission
K191091 also covers:
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI eb729bc8-3efe-4bca-b0d5-a154c50c1324 37 fields · synced May 30, 2026